Passive medical devices
2021-03-25
Announcement of review results of medical device priority approval application (no. 3 [2022])
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- Time of issue:2022-05-31
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(Summary description)
Announcement of review results of medical device priority approval application (no. 3 [2022])
(Summary description)
- Categories:News
- Author:
- Origin:
- Time of issue:2022-05-31
- Views:0
Information
According to the NMPA's "medical device priority approval procedure" , CMDE has reviewed the application for medical device registration that applied for priority approval. The following projects meet the priority approval situation, and are proposed to be given priority approval, and are hereby announced.
|
serial number |
acceptance number |
the product name |
applicant |
grounds for consent |
|
1 |
CSZ2200100 |
PD-L1 ANTIBODY REAGENT (IMMUNOHISTOCHEMISTRY) |
suzhou wuxi zekang biotechnology co., ltd |
the product belongs to the "urgently needed clinically, and there is no medical device approved for registration of the same variety of products in china". |
publicity period: may 25, 2022 to june 1, 2022
During the publicity period, any unit or individual who has objections can fill in the medical device priority approval project objection form and submit it in writing to the center.
contact: zhang xin
tel:010-86452928
email: gcdivision@cmde.org.cn
address: Building 1, No. 50 Meteorological Road, Haidian District, Beijing.
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